Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction
NCT ID: NCT01444911
Last Updated: 2019-12-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
29 participants
INTERVENTIONAL
2011-08-31
2013-05-31
Brief Summary
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In the University of Wisconsin gynecologic oncology and radiation oncology clinics, patients are generally asked about sexual function. Those women who report sexual dysfunction will be given the option to enroll in the study. After enrollment, the Female Sexual Function Index (FSFI) and other quality of life surveys will be administered at baseline. The participants will be randomized to either the control arm, composed of standard of care therapy for the physical components of sexual dysfunction, or the experimental arm (VRP).
Throughout the study, the participants will undergo physical exams to assess the rate of improvement in their comfort with pelvic exams and changes in vaginal length. They will also be evaluated with the FSFI, Marinoff Scale for Dyspareunia, and Functional Assessment of Cancer Therapy-General (FACT-G) surveys at the end of the study to assess the magnitude of improvement in sexual function and quality of life.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Vaginal Renewal Program
Vaginal Renewal Program
The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
Standard of care
This will consist of still vaginal dilator and/or lubricant.
Vaginal Dilator
Still vaginal dilator with lubricant.
Interventions
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Vaginal Renewal Program
The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
Vaginal Dilator
Still vaginal dilator with lubricant.
Eligibility Criteria
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Inclusion Criteria
* History of a gynecologic cancer
* No evidence of disease at time of inclusion in the study
* Postmenopausal (either surgical or natural menopause)
* Self report of sexual dysfunction that did not predate cancer diagnosis
* Suspected physical component to sexual dysfunction with the participant, not sexual partner
* Desire to improve sexual function
* ECOG Performance status score of 2 or better
* Six months or greater from last surgical and/or radiation treatment
Exclusion Criteria
* Presence of vaginal fistula
* Does not desire to improve sexual function
* Already using the vaginal renewal program
* Not fluent in English
* Incarceration
18 Years
FEMALE
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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David M Kushner, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin School of Medicine and Public Health Madison, Wisconsin, United States
Madison, Wisconsin, United States
Countries
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Related Links
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University of Wisconsin Carbone Cancer Center
Other Identifiers
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OS10706
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-03674
Identifier Type: REGISTRY
Identifier Source: secondary_id
A532820
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH\OBSTET & GYNEC\GYNEC ONC
Identifier Type: OTHER
Identifier Source: secondary_id
2011-0217
Identifier Type: -
Identifier Source: org_study_id